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SD Abutment PTA-6510N

by Surgident

SD Abutment PTA-6510N is a Class II device made by Surgident, cleared under FDA 510(k) K173570 on 17 May 2019 and listed in FDA GUDID since 27 Jun 2019 (UDI-DI 08800041008162), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K173570

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800041008162 UDI-DI Date27 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173570 Date17 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173570 decided 17 May 2019 Active
  • FDA GUDID UDI-DI 08800041008162 listed 27 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173570
  2. Listed FDA GUDID 08800041008162

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SD Abutment
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Model / Ref / Catalog
PTA-6510N, TA-6510N
Primary DI / UDI-DI
08800041008162
510(k) Number
FDA product code
NHA
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: Dental implant system

Cleared under the same submission (K173570)

and 8 more cleared under K173570

Similar devices in this category

Other devices filed under Dental implant system.

Other devices from Surgident

See all devices from Surgident →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (8, all answered No)